ARROW IPN922856Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902203004), received between Sep 11, 2024 and Jul 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (1 report).

32 other recalls cover devices cleared under the same FDA submission (K810675); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2026Material Separation; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ATTEMPTED PLACEMENT OF A 20-GAUGE ARTERIAL INTEGRATED GUIDEWIRE CATHETER SYSTEM IN THE LEFT FEMORAL ARTERY UNDER ULTRASOUND GUIDANCE, RESISTANCE WAS ENCOUNTERED AFTER PARTIAL INSERTION OF THE DEVICE, AND FURTHER ADVANCEMENT WAS IMMEDIATELY DISCONTINUED. SUBSEQUENT ATTEMPTS TO WITHDRAW THE DEVICE WERE MET WITH PERSISTENT RESISTANCE. DURING CAREFUL TRACTION, THE SPRING WIRE GUIDE (SWG) REPORTEDLY DEFORMED AND SHEARED, RESULTING IN RETENTION OF A WIRE SEGMENT WITHIN THE ARTERIAL VESSEL. BEDSIDE ULTRASOUND DEMONSTRATED AN ECHOGENIC LINEAR STRUCTURE WITHIN THE WALL OF THE LEFT FEMORAL ARTERY, CONSISTENT WITH A RETAINED GUIDEWIRE SEGMENT, WHICH APPEARED TO BE ADJACENT TO THE TUNICA MEDIA. NO IMMEDIATE EVIDENCE OF ACTIVE EXTRAVASATION, PSEUDOANEURYSM, OR EXPANDING HEMATOMA WAS OBSERVED. FURTHER MANIPULATION OF THE DEVICE WAS CEASED IMMEDIATELY. THE EXTERNAL PORTION OF THE WIRE WAS SECURED WITH HEMOSTATS TO PREVENT MIGRATION. HEMOSTASIS WAS MAINTAINED, AND THE INSERTION SITE WAS COVERED WITH A STERILE DRESSING AND A CHLORHEXIDINE GLUCONATE (CHG) IMPREGNATED PROTECTIVE DISK DRESSING. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR REMO

  Patient problems: Foreign Body In Patient

  MAUDE report 25706730 ↗
• InjurySep 11, 2024

  DURING REMOVAL OF AN ARTERIAL LINE, THE CATHETER REMAINED IN THE PATIENT REQUIRING SURGICAL INTERVENTION FOR REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20189072 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810675. One submission often covers many models, so check the product and lot details in each record.

• Z-2397-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18
• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
• Z-0844-2020 · Dec 12, 2019 · Open, Classified
  Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1330-2018 · Dec 22, 2017 · Terminated
  (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Fea
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120

…and 17 more.